PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 80oz WITH LID (10) LAP SPONGE PREWASH XRD LIF (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) EAR ULCER SYRINGE 2oz LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CORD UMBILICAL CLAMP LIF (1) DRESSING ISLAND 4" X 10" (1) BLADE SURGICAL#10 CARBON STEEL (1) BLADE SURGICAL#20 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) C-SECTION DRAPE WITH POUCH (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI III (1) GOWN SURG. REINFORCED LARGE AAMI III TOWEL WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2382-2014
- Event ID
- 68536
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Customed, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 10, 2014
- Initiation Date
- May 20, 2014
- Classification Date
- August 29, 2014
- Termination Date
- August 14, 2017
- Address
- Calle Igualdad Final #7, Fajardo, PR, 00738, United States
Description
PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 80oz WITH LID (10) LAP SPONGE PREWASH XRD LIF (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) EAR ULCER SYRINGE 2oz LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CORD UMBILICAL CLAMP LIF (1) DRESSING ISLAND 4" X 10" (1) BLADE SURGICAL#10 CARBON STEEL (1) BLADE SURGICAL#20 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) C-SECTION DRAPE WITH POUCH (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI III (1) GOWN SURG. REINFORCED LARGE AAMI III TOWEL WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Product code 900-1294, 18 lots: 111030560 111030815 112020527 112114630 112124933 113015688 113026042 113036408 113057858 113089182 113109717 131110166 131210694 140211638 140312063 140412594 140513078 140513477
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
18 lots; 730 units (multiple units per lot)